Back to resultsStudy of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis (TDLRipsy)
Primary Purpose
Psychosis, Schizophrenia, At-risk Mental State
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Language assessment
TLC - Scale for the Assessment of Thought, Language, and Communication
MINI - Mini International Neuropsychiatric Interview
CAST - Cannabis Abuse Screening Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Psychosis
Eligibility Criteria
Inclusion Criteria: All Groups: Patient affiliated or entitled to a social security scheme Patient having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study For minor participants, at least one of the parents or holders of parental authority having been informed of the study, having received the information note relating to it and not having objected to the participation of his or her child Native language: French ARMS and FEP Patient Group: Age between 16 and 35 years old Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment of At Risk Mental State (CAARMS) or present the criteria for Disorders of the course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A) Patients with schizophrenia group: Age between 16 and 55 years old Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American Psychiatric Association, 2015) Present the criteria for Disorganization of Speech and Formal Thought Disorder as defined by the Thinking, Language and Communication (TLC) Rating Scale. Healthy Volunteers Group: Age between 16 and 55 years old Parental authorization (of both parents) to participate in the study for minor patients Exclusion Criteria: All groups: Pregnant, parturient or nursing mother Person deprived of liberty by a judicial or administrative decision Person in a life-threatening emergency Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Adult person unable to express their consent and who is not the subject of a legal protection measure Impairment of the subject making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them Abuse or dependence of any substance according to DSM V criteria excluding cannabis Healthy Volunteers Group: Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI) excluding anxiety disorder Presence of developmental disorder of oral language or written language revealed on clinical examination.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
early psychotic symptoms
patients with schizophrenia
healthy controls
Arm Description
This group includes patients with ARMS and those with FEP. Although they are not in the same place in the continuum of psychosis, these patients benefit from the same language assessment and CAST, do not benefit from the TLC or the MINI, and the data from their neuropsychological and psychiatric assessment will be used , which is why we have chosen to bring them together in the same arm. They are between 16 and 35 years old and are cared for as part of their usual follow-up at the CPN (Nancy Psychotherapeutic Center). They must have received the diagnosis of ARMS and FEP according to the criteria of CAARMS and SPI-A.
The schizophrenic patients group will benefit from language assessment, TLC and CAST. They are between 18 and 55 years old and are cared for as part of their usual follow-up at the CPN. They must have been diagnosed with schizophrenia according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria.
The control group for this study will be made up of volunteers between the ages of 16 and 55, not suffering from any mental disorder detected on the MINI or from a developmental disorder of oral or written language. They will also benefit from an assessment of cannabis use using the CAST.
Outcomes
Primary Outcome Measures
language assessment performance score
complete speech therapy assessment evaluating each language domain. and is based on the completion of a speech therapy assessment test and on the assessment of language abilities by the experimental speech therapist.
Secondary Outcome Measures
CAARMS Speech Disorganization Severity Score
CAARMS: Comprehensive Assessment of At Risk Mental State
Severity score for the disordered items of the course of thought of the SPI-A
SPI-A:Schizophrenia Proneness Instrument
Severity score for speech disorganization and formal thought disorders on the TLC Scale
TLC: Thinking, Language and Communication Rating Scale
Neuropsychological rating scales scores (CVLT)
CVLT (California Verbal Learning test) (quantitative variable):
CVLT: number of correct recognitions
Neuropsychological rating scales scores (CVLT total)
CVLT (California Verbal Learning test) (quantitative variable):
CVLT total: total number of words recalled during the test Recognition
Neuropsychological rating scales scores (Front and back spans)
Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)
Neuropsychological rating scales scores (Front and back spans 2)
Front and back spans (quantitative variable) Reverse span size (number of digits recalled in reverse order)
Neuropsychological rating scales scores (TAP 1)
TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
Neuropsychological rating scales scores (TAP 2)
TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
Neuropsychological rating scales scores (TAP 3)
TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)
Neuropsychological rating scales scores (TAP 4)
TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)
Neuropsychological rating scales scores (TAP 5)
TAP- Divided attention
Cannabis Abuse Screening Test (CAST) score
CAST: Cannabis Abuse Screening Test
Full Information
NCT ID
NCT06036316
First Posted
September 1, 2023
Last Updated
September 12, 2023
Sponsor
Centre Psychothérapique de Nancy
1. Study Identification
Unique Protocol Identification Number
NCT06036316
Brief Title
Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
Acronym
TDLRipsy
Official Title
Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Psychothérapique de Nancy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research concerns the study of language disorders of patients present in the spectrum of psychosis. It is indeed accepted that psychotic disorders are associated with language difficulties, which are only poorly highlighted thanks to reusable tools in clinical practice. These language disorders impact communication, and concern many linguistic domains, thus covering phonology, lexicon, semantics, morphosyntax and pragmatics. It therefore seems relevant to characterize these language disorders and to assess to what extent they interact with the other symptoms of the pathology, in particular the course of the thought disorder and the neuropsychological symptoms. In addition, this study is particularly interested in the interactions between working memory capacities and those related to syntax. It is intended for different patients suffering from psychotic disorders of different intensities, treated in the Psychotherapeutic Center of Nancy. Patients suffering from at-risk mental state (ARMS), first episode of psychosis (FEP) or schizophrenia will benefit from a complete language assessment, evaluating each domain mentioned above, on the expressive and understanding sides. The results of the language assessment will be compared with those of a control group in the same tests. They will also be analyzed with regard to the neuropsychological and psychiatric elements noted in the patient's medical file, in order to highlight possible associations between language skills, neuropsychological and psychiatric symptoms in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia, At-risk Mental State, Language Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early psychotic symptoms
Arm Type
Experimental
Arm Description
This group includes patients with ARMS and those with FEP. Although they are not in the same place in the continuum of psychosis, these patients benefit from the same language assessment and CAST, do not benefit from the TLC or the MINI, and the data from their neuropsychological and psychiatric assessment will be used , which is why we have chosen to bring them together in the same arm. They are between 16 and 35 years old and are cared for as part of their usual follow-up at the CPN (Nancy Psychotherapeutic Center). They must have received the diagnosis of ARMS and FEP according to the criteria of CAARMS and SPI-A.
Arm Title
patients with schizophrenia
Arm Type
Experimental
Arm Description
The schizophrenic patients group will benefit from language assessment, TLC and CAST. They are between 18 and 55 years old and are cared for as part of their usual follow-up at the CPN. They must have been diagnosed with schizophrenia according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria.
Arm Title
healthy controls
Arm Type
Experimental
Arm Description
The control group for this study will be made up of volunteers between the ages of 16 and 55, not suffering from any mental disorder detected on the MINI or from a developmental disorder of oral or written language. They will also benefit from an assessment of cannabis use using the CAST.
Intervention Type
Behavioral
Intervention Name(s)
Language assessment
Other Intervention Name(s)
Speech and language therapy assessment
Intervention Description
The proposed speech and language therapy assessment will consist of a battery of standardized tests that speech and language therapists can use to assess the language skills in reception and expression of adult patients.
Concerning the assessment of the interactions between working memory and semantic abilities, a complete protocol has been developed.
Intervention Type
Behavioral
Intervention Name(s)
TLC - Scale for the Assessment of Thought, Language, and Communication
Intervention Description
This scale is frequently used in psychiatry and is used to measure formal thought disorders in patients suffering from psychosis. As part of this study, it will be intended for patients suffering from schizophrenia
Intervention Type
Behavioral
Intervention Name(s)
MINI - Mini International Neuropsychiatric Interview
Intervention Description
This scale corresponds to a rapid assessment of the psychiatric and psychological state of patients. It helps detect any psychiatric disorders. Here, it will be offered to volunteers who are part of the control group.
Intervention Type
Combination Product
Intervention Name(s)
CAST - Cannabis Abuse Screening Test
Intervention Description
The purpose of this questionnaire is to approximate participants' cannabis consumption and to assess any disorders associated with cannabis consumption. It will be offered to all participants, patients and healthy controls
Primary Outcome Measure Information:
Title
language assessment performance score
Description
complete speech therapy assessment evaluating each language domain. and is based on the completion of a speech therapy assessment test and on the assessment of language abilities by the experimental speech therapist.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
CAARMS Speech Disorganization Severity Score
Description
CAARMS: Comprehensive Assessment of At Risk Mental State
Time Frame
day 1
Title
Severity score for the disordered items of the course of thought of the SPI-A
Description
SPI-A:Schizophrenia Proneness Instrument
Time Frame
day 1
Title
Severity score for speech disorganization and formal thought disorders on the TLC Scale
Description
TLC: Thinking, Language and Communication Rating Scale
Time Frame
day 1
Title
Neuropsychological rating scales scores (CVLT)
Description
CVLT (California Verbal Learning test) (quantitative variable):
CVLT: number of correct recognitions
Time Frame
day 1
Title
Neuropsychological rating scales scores (CVLT total)
Description
CVLT (California Verbal Learning test) (quantitative variable):
CVLT total: total number of words recalled during the test Recognition
Time Frame
day 1
Title
Neuropsychological rating scales scores (Front and back spans)
Description
Front and back spans (quantitative variable) Front span size (number of digits recalled in front order)
Time Frame
day 1
Title
Neuropsychological rating scales scores (Front and back spans 2)
Description
Front and back spans (quantitative variable) Reverse span size (number of digits recalled in reverse order)
Time Frame
day 1
Title
Neuropsychological rating scales scores (TAP 1)
Description
TAP- Working Memory :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
Time Frame
day 1
Title
Neuropsychological rating scales scores (TAP 2)
Description
TAP- Sustained attention :Number of omissions TAP(Test of Attentional Performance) (quantitative variable)
Time Frame
day 1
Title
Neuropsychological rating scales scores (TAP 3)
Description
TAP- Flexibility :Number of errors TAP(Test of Attentional Performance) (quantitative variable)
Time Frame
day 1
Title
Neuropsychological rating scales scores (TAP 4)
Description
TAP- Incompatibility TAP(Test of Attentional Performance) (quantitative variable)
Time Frame
day 1
Title
Neuropsychological rating scales scores (TAP 5)
Description
TAP- Divided attention
Time Frame
day 1
Title
Cannabis Abuse Screening Test (CAST) score
Description
CAST: Cannabis Abuse Screening Test
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All Groups:
Patient affiliated or entitled to a social security scheme
Patient having received informed information on the study and having co-signed, with the investigator, a consent to participate in the study
For minor participants, at least one of the parents or holders of parental authority having been informed of the study, having received the information note relating to it and not having objected to the participation of his or her child
Native language: French
ARMS and FEP Patient Group:
Age between 16 and 35 years old
Present the criteria for EMRP or FEP as defined by the Comprehensive Assessment of At Risk Mental State (CAARMS) or present the criteria for Disorders of the course of thought to the items of the Schizophrenia Proneness Instrument (SPI-A)
Patients with schizophrenia group:
Age between 16 and 55 years old
Patient with diagnostic criteria for schizophrenia, as defined by DSM V (American Psychiatric Association, 2015)
Present the criteria for Disorganization of Speech and Formal Thought Disorder as defined by the Thinking, Language and Communication (TLC) Rating Scale.
Healthy Volunteers Group:
Age between 16 and 55 years old
Parental authorization (of both parents) to participate in the study for minor patients
Exclusion Criteria:
All groups:
Pregnant, parturient or nursing mother
Person deprived of liberty by a judicial or administrative decision
Person in a life-threatening emergency
Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
Adult person unable to express their consent and who is not the subject of a legal protection measure
Impairment of the subject making it difficult, if not impossible, for them to participate in the trial or to understand the information given to them
Abuse or dependence of any substance according to DSM V criteria excluding cannabis
Healthy Volunteers Group:
Evolving psychiatric pathology (axis I of the DSM IV, measured at the MINI) excluding anxiety disorder
Presence of developmental disorder of oral language or written language revealed on clinical examination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anaëlle PAJAUD
Phone
0383260863
Email
Anaelle.PAJAUD@cpn-laxou.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naoual MELLOUKI, PhD
Phone
0383925267
Email
Naoual.MELLOUKIBENDIMRED@cpn-laxou.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florent Bernardin, PhD
Organizational Affiliation
Centre psychothérapeutique de Nancy
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23874280
Citation
Majerus S. Language repetition and short-term memory: an integrative framework. Front Hum Neurosci. 2013 Jul 12;7:357. doi: 10.3389/fnhum.2013.00357. eCollection 2013.
Results Reference
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Study of Language Disorders and Interactions Between Mnesic Capabilities and Semantic Competencies in Patients With Psychosis
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